Összesen 1 találat.


001-es BibID:BIBFORM102302
035-os BibID:(WOS)000805325600001 (Scopus)85132198667
Első szerző:Boers, Maarten
Cím:Low dose, add-on prednisolone in patients with rheumatoid arthritis aged 65+ : the pragmatic randomised, double-blind placebo-controlled GLORIA trial / Maarten Boers, Linda Hartman, Daniela Opris-Belinski, Reinhard Bos, Marc R. Kok, Jose A. P. Da Silva, Eduard N. Griep, Ruth Klaasen, Cornelia F. Allaart, Paul Baudoin, Hennie G. Raterman, Zoltan Szekanecz, Frank Buttgereit, Pavol Masaryk, L. Thomas Klausch, Sabrina Paolino, Annemarie M. Schilder, Willem F. Lems, Maurizio Cutolo, GLORIA Trial consortium
Megjegyzések:Background Low-dose glucocorticoid (GC) therapy is widely used in rheumatoid arthritis (RA) but the balance of benefit and harm is still unclear. Methods The GLORIA (Glucocorticoid LOw-dose in RheumatoId Arthritis) pragmatic double-blind randomised trial compared 2 years of prednisolone, 5 mg/day, to placebo in patients aged 65+ with active RA. We allowed all cotreatments except long-term open label GC and minimised exclusion criteria, tailored to seniors. Benefit outcomes included disease activity (disease activity score; DAS28, coprimary) and joint damage (Sharp/van der Heijde, secondary). The other coprimary outcome was harm, expressed as the proportion of patients with ?1 adverse event (AE) of special interest. Such events comprised serious events, GC-specific events and those causing study discontinuation. Longitudinal models analysed the data, with one-sided testing and 95% confidence limits (95% CL). Results We randomised 451 patients with established RA and mean 2.1 comorbidities, age 72, disease duration 11 years and DAS28 4.5. 79% were on disease-modifying treatment, including 14% on biologics. 63% prednisolone versus 61% placebo patients completed the trial. Discontinuations were for AE (both, 14%), active disease (3 vs 4%) and for other (including covid pandemic-related disease) reasons (19 vs 21%); mean time in study was 19 months. Disease activity was 0.37 points lower on prednisolone (95% CL 0.23, p<0.0001); joint damage progression was 1.7 points lower (95% CL 0.7, p=0.003). 60% versus 49% of patients experienced the harm outcome, adjusted relative risk 1.24 (95% CL 1.04, p=0.02), with the largest contrast in (mostly non-severe) infections. Other GC-specific events were rare. Conclusion Add-on low-dose prednisolone has beneficial long-term effects in senior patients with established RA, with a trade-off of 24% increase in patients with mostly non-severe AE; this suggests a favourable balance of benefit and harm.
Tárgyszavak:Orvostudományok Klinikai orvostudományok idegen nyelvű folyóiratközlemény külföldi lapban
Megjelenés:Annals Of The Rheumatic Diseases. - 81 : 7 (2022), p. 925-936. -
További szerzők:Hartman, Linda Opris, Daniela (1976-) (reumatológus) Bos, Reinhard Kok, Marc R. Da Silva, Jose A. P. Griep, Eduard N. Klaasen, Ruth Allaart, Cornelia F. Baudoin, Paul Raterman, Hennie G. Szekanecz Zoltán (1964-) (reumatológus, belgyógyász, immunológus) Buttgereit, Frank Masaryk, Pavol Klausch, Thomas Paolino, Sabrina Schilder, Annemarie M. Lems, Willem F. Cutolo, Maurizio GLORIA Trial consortium
Internet cím:Szerző által megadott URL
Intézményi repozitóriumban (DEA) tárolt változat
Rekordok letöltése1